Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001158156
Ethics application status
Approved
Date submitted
1/08/2019
Date registered
19/08/2019
Date last updated
19/08/2019
Date data sharing statement initially provided
19/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A web-based intervention to increase child intake of fruit and vegetables within childcare centres
Scientific title
A cluster randomised controlled trial of a web-based intervention to increase child intake of fruit and vegetables within childcare centres
Secondary ID [1] 298905 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutrition 313881 0
Condition category
Condition code
Public Health 312294 312294 0 0
Health promotion/education
Diet and Nutrition 312295 312295 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The six month intervention will target nominated supervisors and staff within childcare centres and support their implementation of five healthy eating practices. Specifically, childcare centres will be asked to implement the following targeted healthy eating practices within the intervention period: 1. Supporting families to provide healthier foods consistent with dietary guidelines; 2. Provision of intentional learning experiences about healthy eating to children; 3. Use of feeding practices that support children’s healthy eating; 4. Staff participation in professional development in healthy eating; 5. Comprehensive written nutrition policy that outlines key healthy eating.

Childcare centres allocated to the intervention will receive support from health promotion officers (HPO) within the local health district with experience working with childcare centres. Support to implement the intervention (i.e. healthy eating practices) will include:
1. Audit and feedback: The web-based program includes a self-assessment of the implementation of targeted healthy eating practices. Following the completion of the self-assessment, the web-based program will immediately provide centres with feedback on practice performance.
2. Develop a formal implementation blueprint: Following the completion of the self-assessment, centres will then be encouraged to set goals and create an action plan within the web-based program to facilitate improvements in practice.
3. Distribution of educational materials: The web-based program will house relevant materials designed to assist centre implementation of healthy eating practices, and include: factsheets, email messages and newsletter snippets to facilitate communication with parents regarding children’s lunchbox contents alignment with guidelines; educational materials to improve staff knowledge of providing a positive healthy eating environment; example activities to demonstrate intentional nutrition learning experiences within the centre; directions to online learning opportunities, including webinars and eLearning modules to support staff professional development in nutrition; and nutrition policy templates.
4. Identify and prepare a centre champion: Centres will be asked by the HPO to identify and prepare a staff member from the centre who will dedicate themselves to supporting, marketing and driving implementation of the intervention.
5. Educational outreach visit from a HPO: Centre staff (nominated supervisor and centre champion) will receive one face-to-face training session of approximately two hours by a HPO to support implementation of the healthy eating practices and introduce the web-based program at the beginning of the intervention period. This will be a practical, hands-on training session to ensure staff are comfortable using the web-based program, accessing supporting resources and are aware of the key practices targeted by the intervention.
6. Mandate change: Centre nominated supervisors will be asked by the HPO to show support for implementing targeted healthy eating practices and use of the web-based program via a memorandum of understanding, which will outline the responsibilities and expected commitment from both the childcare centre and HPO in working to improve the implementation of healthy eating practices to improve child dietary intake in care.
7. Provide ongoing consultation and local technical assistance: Childcare centre staff will be provided with approximately two telephone calls pending childcare centre needs by the HPOs who conducted the educational outreach visit. The HPOs providing the support will identify centre barriers to implementing the intervention and web-based program, and discuss strategies address these barriers. Email support will be provided by HPOs upon request by the centre. An additional training session delivered via online modalities will be offered to centres, pending childcare centre needs.

Adherence to the intervention will monitored via observations of centre implementation of healthy eating practices, google analytics regularly captured by the web-based program, and internal records detailing the provision of implementation strategies including selection of a centre champion, educational outreach visit, centre staff signatories on the memorandum of understanding, and provision of ongoing consultation and technical assistance, maintained by the research team.
Intervention code [1] 315179 0
Prevention
Intervention code [2] 315180 0
Behaviour
Comparator / control treatment
The control group will receive usual care during the intervention period. Usual care includes general support from a health promotion officer upon request to implement the state-wide obesity prevention program. Centres will be provided with access to the web-based program following the completion of the trial.
Control group
Active

Outcomes
Primary outcome [1] 320929 0
Mean serves of fruit from all food and beverages consumed whilst in care.
This will be assessed through the measurement of lunchbox foods and beverages across the day. Two trained research assistants will assess the lunchboxes of participating children. Measurement of lunchbox contents will be conducted on two occasions across the day. Prior to the children’s first meal, a photo will be taken of the entire lunchbox contents. Research assistants will then weigh each food item included in the lunchbox. This process will be repeated after the children’s last meal. Consumption will be calculated based on foods and beverages present at the first measurement minus foods remaining at the second measurement. Weighed food record data will be entered into a nutrient analysis software by a dietitian and categorised into food groups to calculate mean serves of fruit consumed in accordance with the serve sizes specified within the Australian Guide to Healthy Eating.
Timepoint [1] 320929 0
Baseline and approximately 6 months follow up
Primary outcome [2] 321055 0
Mean serves of vegetables from all food and beverages consumed whilst in care.
This will be assessed through the measurement of lunchbox foods and beverages across the day. Two trained research assistants will assess the lunchboxes of participating children. Measurement of lunchbox contents will be conducted on two occasions across the day. Prior to the children’s first meal, a photo will be taken of the entire lunchbox contents. Research assistants will then weigh each food item included in the lunchbox. This process will be repeated after the children’s last meal. Consumption will be calculated based on foods and beverages present at the first measurement minus foods remaining at the second measurement. Weighed food record data will be entered into a nutrient analysis software by a dietitian and categorised into food groups to calculate mean serves of vegetables consumed in accordance with the serve sizes specified within the Australian Guide to Healthy Eating.
Timepoint [2] 321055 0
Baseline and approximately 6 months follow up
Secondary outcome [1] 373372 0
Mean serves of vegetables packed within lunchboxes assessed through the measurement of lunchbox foods and beverages across the day. Two trained research assistants will assess the lunchboxes of participating children. Prior to the children’s first meal, a photo will be taken of the entire lunchbox contents. Research assistants will then weigh each food item included in the lunchbox. Weighed food record data will be entered into a nutrient analysis software by a dietitian and categorised into food groups to calculate mean serves vegetables packed within lunchboxes in accordance with the serve sizes specified within the Australian Guide to Healthy Eating.
Timepoint [1] 373372 0
Baseline and approximately 6 months follow up
Secondary outcome [2] 373373 0
Mean serves of fruit packed within lunchboxes assessed through the measurement of lunchbox foods and beverages across the day. Two trained research assistants will assess the lunchboxes of participating children. Prior to the children’s first meal, a photo will be taken of the entire lunchbox contents. Research assistants will then weigh each food item included in the lunchbox. Weighed food record data will be entered into a nutrient analysis software by a dietitian and categorised into food groups to calculate mean serves of fruit packed within lunchboxes in accordance with the serve sizes specified within the Australian Guide to Healthy Eating.
Timepoint [2] 373373 0
Baseline and approximately 6 months follow up
Secondary outcome [3] 373374 0
Mean child dietary intake of sodium (mg) in care assessed through the measurement of lunchbox foods and beverages across the day. Two trained research assistants will assess the lunchboxes of participating children. Measurement of lunchbox contents will be conducted on two occasions across the day: prior to the children’s first meal time and after the children’s last meal time. Prior to the children’s first meal, a photo will be taken of the entire lunchbox contents. Research assistants will then weigh each food item included in the lunchbox. This process will be repeated after the children’s last meal. Consumption will be calculated based on foods and beverages present at the first measurement minus foods remaining at the second measurement. Weighed food record data will be entered into a nutrient analysis software by a dietitian. The nutrient output provided by weighed food record data will be used to assess child intake of sodium (mg).
Timepoint [3] 373374 0
Baseline and approximately 6 months follow up
Secondary outcome [4] 373375 0
Mean child dietary intake of added sugar (g) in care assessed through the measurement of lunchbox foods and beverages across the day. Two trained research assistants will assess the lunchboxes of participating children. Measurement of lunchbox contents will be conducted on two occasions across the day: prior to the children’s first meal time and after the children’s last meal time. Prior to the children’s first meal, a photo will be taken of the entire lunchbox contents. Research assistants will then weigh each food item included in the lunchbox. This process will be repeated after the children’s last meal. Consumption will be calculated based on foods and beverages present at the first measurement minus foods remaining at the second measurement. Weighed food record data will be entered into a nutrient analysis software by a dietitian. The nutrient output provided by weighed food record data will be used to assess child intake of added sugar (g).
Timepoint [4] 373375 0
Baseline and approximately 6 months follow up
Secondary outcome [5] 373376 0
Mean child dietary intake of saturated fat (g) in care assessed through the measurement of lunchbox foods and beverages across the day. Two trained research assistants will assess the lunchboxes of participating children. Measurement of lunchbox contents will be conducted on two occasions across the day: prior to the children’s first meal time and after the children’s last meal time. Prior to the children’s first meal, a photo will be taken of the entire lunchbox contents. Research assistants will then weigh each food item included in the lunchbox. This process will be repeated after the children’s last meal. Consumption will be calculated based on foods and beverages present at the first measurement minus foods remaining at the second measurement. Weighed food record data will be entered into a nutrient analysis software by a dietitian. The nutrient output provided by weighed food record data will be used to assess saturated fat (g).
Timepoint [5] 373376 0
Baseline and approximately 6 months follow up
Secondary outcome [6] 373377 0
Childcare centre implementation of the targeted healthy eating practices (intervention adherence) will be assessed with the Environmental and Policy Assessment and Observation (EPAO) tool. This tool has been previously validated and is considered to be the gold standard for environment observations in the childcare setting. Per EPAO protocol, a trained RA will undertake a one-day observation and review of childcare centre documentation.
Timepoint [6] 373377 0
Baseline and approximately 6 months follow up
Secondary outcome [7] 373378 0
Childcare centre uptake of implementation strategies, including use of the web-based program will be assessed through data provided via Google Analytics. These analytics include, but not limited to, total time logged into the program, completion of the self-assessment, most frequently used program features and the number of requests for assistance. Internal records detailing the provision of implementation strategies including the educational outreach visit, ongoing consultation and local technical assistance, memorandum of understanding and identification of a centre champion will be maintained by research team members.
Timepoint [7] 373378 0
End of the intervention period (approximately 6 months follow up)
Secondary outcome [8] 373822 0
Feasibility of the intervention for a fully-powered implementation trial will be assessed through childcare centre and parent recruitment, and consent rates for each component of data collection. Appropriateness of the intervention and implementation strategies will be evaluated through information collected during telephone interviews with centre supervisors and champions.
Timepoint [8] 373822 0
End of the intervention period (approximately 6 months follow up)
Secondary outcome [9] 373823 0
Factors associated with implementation of healthy eating practices will be assessed during a telephone interview with childcare supervisors using items from three of the five domains of the Consolidated Framework for Implementation Research (inner setting (compatibility with centre values and direction, level of priority); innovation characteristics (perceived complexity and cost); and outer setting (external influences such as policies, regulations and peer behaviour)).
Timepoint [9] 373823 0
End of the intervention period (approximately 6 months follow up)
Secondary outcome [10] 373826 0
Acceptability and scalability of implementation strategies and intervention will be assessed via a telephone interview conducted with supervisors and champions from centres allocated to the intervention group. This telephone interview will include items previously used by the research team to assess perceived intervention effectiveness, unintended consequences, reach and adoption, acceptability and feasibility and engagement with the web-based program.
Timepoint [10] 373826 0
End of intervention period (approximately 6 months follow up)

Eligibility
Key inclusion criteria
Centre-based childcare services (long day care services and preschools)
To be eligible, childcare centres must: (1) enrol >20 children per day; (2) have internet access at the centre; (3) not provide meals or snacks to children (i.e. parents or caregivers must be required to provide food packed in lunchboxes); (4) not be currently participating in any other intervention to improve child healthy eating and/or physical activity; and (5) not be fully compliant with healthy eating practices specified in the NSW state obesity prevention program.

Children
In order for children to be eligible to participate, they must: (1) have prior written consent from a parent or guardian; (2) be between the ages of 2 and 5 years.
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Centre-based childcare services (long day care services and preschools)
Mobile preschool, family day care centres, and centres that do not cater to children aged 2-5 years; cater exclusively for children requiring specialist care; or are run by the Department of Education and Communities Centre will be excluded due to differing operational characteristics.

Children
Children with dietary restrictions that require specialised tailoring of their diet (e.g. allergies, intellectual or physical disability).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Childcare centres
A list of potentially eligible childcare centres located within the HNE region will be provided by the NSW Ministry of Health. A recruitment package will be progressively distributed to potentially eligible centres in random order. A research assistant will then telephone centres in random order to assess eligibility and request consent for study participation. The research assistant will schedule a two-day site visit to complete baseline data collection for consenting centres. Randomisation will be completed following baseline data collection by a statistician with no involvement in the trial.

Children
Centres will be asked to distribute parent information statements and consent forms via email, parent communication apps, and child pigeonholes. Prior to, and on the day of the scheduled site visits, two research assistants will be present at the childcare centre to request written consent from parents for child participation in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Childcare centres will be randomly allocated following a block randomisation procedure in a 1:1 ratio using a computerised random number function in Microsoft Excel 2013 by a trained statistician not otherwise involved in the trial. Randomisation will be stratified by centres with a high number of Aboriginal child enrolments (>10%) and socioeconomic status.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to describe childcare centre and child characteristics, the appropriateness, feasibility, acceptability and scalability of the intervention, and determinants of implementation. At the child level, mixed linear regression models will be run, where a group by time interaction will assess effectiveness of the intervention. All models will include a random effect for childcare centre to account for potential clustering effect, as well as fixed effects for prognostic variables (SES, gender). Scores of the EPAO will be adjusted for baseline, through linear regression analysis.

Given a 10% childcare centre attrition rate at follow up, recruitment of approximately 440 children from 22 childcare centres (20 children per centre) will enable detection of a mean difference of 0.3 serves in the primary outcome, with an alpha of 0.05 and an estimated ICC of 0.1, with 80% power and a standard deviation of 0.6 serves. This number of participants will allow detection of a difference of approximately 1.9g saturated fat, 4.7g added sugar and 155 mg sodium.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
22
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303449 0
Government body
Name [1] 303449 0
Hunter New England Population Health
Country [1] 303449 0
Australia
Funding source category [2] 303451 0
Charities/Societies/Foundations
Name [2] 303451 0
Hunter Children’s Research Foundation (HCRF)
Country [2] 303451 0
Australia
Funding source category [3] 303452 0
Other
Name [3] 303452 0
Hunter Medical Research Institute (HMRI)
Country [3] 303452 0
Australia
Funding source category [4] 303453 0
University
Name [4] 303453 0
Priority Research Centre for Health Behaviour, University of Newcastle
Country [4] 303453 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan, NSW 2308, Australia
Country
Australia
Secondary sponsor category [1] 303504 0
Government body
Name [1] 303504 0
Hunter New England Population Health
Address [1] 303504 0
Longworth Avenue, Wallsend, NSW 2287
Country [1] 303504 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303982 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 303982 0
Ethics committee country [1] 303982 0
Australia
Date submitted for ethics approval [1] 303982 0
29/03/2019
Approval date [1] 303982 0
16/04/2019
Ethics approval number [1] 303982 0
06/07/26/4.04
Ethics committee name [2] 303983 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 303983 0
Ethics committee country [2] 303983 0
Australia
Date submitted for ethics approval [2] 303983 0
07/05/2019
Approval date [2] 303983 0
08/05/2019
Ethics approval number [2] 303983 0
H-2008-0343

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95454 0
Dr Alice Grady
Address 95454 0
University of Newcastle
c/o Booth Building, Longworth Avenue
Wallsend 2287 NSW
Australia
Country 95454 0
Australia
Phone 95454 0
+61 2 4924 6310
Fax 95454 0
Email 95454 0
[email protected]
Contact person for public queries
Name 95455 0
Alice Grady
Address 95455 0
University of Newcastle
c/o Booth Building, Longworth Avenue
Wallsend 2287 NSW
Australia
Country 95455 0
Australia
Phone 95455 0
+61 2 4924 6310
Fax 95455 0
Email 95455 0
[email protected]
Contact person for scientific queries
Name 95456 0
Alice Grady
Address 95456 0
University of Newcastle
c/o Booth Building, Longworth Avenue
Wallsend 2287 NSW
Australia
Country 95456 0
Australia
Phone 95456 0
+61 2 4924 6310
Fax 95456 0
Email 95456 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual participant data for this trial will be available as ethics approval does not cover this. If a request for individual participant data is made and appropriate ethics approvals obtained, such data may be made available in the future.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA pilot randomised controlled trial of a web-based implementation intervention to increase child intake of fruit and vegetables within childcare centres.2020https://dx.doi.org/10.1186/s40814-020-00707-w
N.B. These documents automatically identified may not have been verified by the study sponsor.